SelectSecure 3830 Lead Imaging

March 14, 2022 updated by: Medtronic Cardiac Rhythm and Heart Failure
This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Associates in Cardiology PA
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Lourdes Cardiology Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.

Description

Inclusion Criteria:

  • Patients who are at least 18 years of age
  • Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
  • Patients able and willing to attend imaging session
  • Patients able and willing to give informed consent
  • Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
  • Patient must be able to accomplish arm flexion and adduction past 90 degrees

Exclusion Criteria:

  • Subjects who require a legally authorized representative to obtain consent
  • Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
  • Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
  • Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects undergoing bi-plane fluoroscopy
Diagnostic test: Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
Time Frame: approximately 30 minutes
Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.
approximately 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquire accelerometer-based motion data
Time Frame: approximately 30 minutes
During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images.
approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 24, 2019

Primary Completion (ACTUAL)

November 3, 2020

Study Completion (ACTUAL)

November 15, 2021

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT18066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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